A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily (OD) Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes

Novo Nordisk A/S458 enrolled

Overview

This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin degludec in inadequately treated subjects with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

458

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin degludecDRUG

Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD with the option to vary time of administration within a window of plus/minus 8 hours. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

insulin degludecDRUG

Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD at the same time each day. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

insulin degludecDRUG

Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered subcutaneously (under the skin) OD at the same time each day. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Current treatment with IGlar (insulin glargine) with or without OADs (oral antidiabetic drug). All antidiabetic treatments should have been on-going for at least 12 weeks prior to randomisation, and doses of OADs should have been stable in this period of time. - Please note that a maximum of 3 OADs are allowed during this trial: metformin, sulphonylurea (SU)/glinides, dipeptidyl peptidase 4 (DPP-IV) inhibitors, alfa-glucosidaseinhibitors or pioglitazone. * Diagnosis of T2DM (type 2 diabetes mellitus) at the discretion of the investigator for at least 26 weeks prior to visit 1 (Screening visit) * HbA1c 7.0-9.5% (both inclusive) by central laboratory analysis * Body mass index (BMI) equal to or below 35 kg/m\^2 Exclusion Criteria: * Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol * Stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 26 weeks prior to Visit 1 (Screening visit) * Impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dL for males and higher than or equal to 1.3 mg/dL for females * Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma) * Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to randomisation

Locations (40)

Outcomes

Primary Outcomes

Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)

Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)

Time frame: Week 0, week 26

Secondary Outcomes

Change From Baseline in Fasting Plasma Glucose (FPG)

Changes from baseline in FPG values over the time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).

Time frame: Week 0, week 26

Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial

The number of subjects who achieved the pre-defined HbA1c target (\<7.0%) after 26 weeks of treatment was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).

Time frame: After 26 weeks of treatment

Incidence of Treatment Emergent Adverse Events (TEAEs)

The incidences of treatment emergent adverse events (TEAEs) over the time period of Week 0-26 were recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).

Time frame: Weeks 0-26

Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL))

The confirmed hypoglycaemic episodes (defined as severe hypoglycaemia and/or a measured plasma glucose (PG) less than 3.1 mmol/L \[less than 56 mg/dL\]) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).

Time frame: Weeks 0-26

Data from ClinicalTrials.gov

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